New approach aims to make repeat radiation safer for cancer patients
NCT ID NCT05301101
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study looks at a standardized method for giving high-dose radiation a second time to people with solid tumors that have come back. It uses advanced imaging to better calculate radiation doses to sensitive organs like the spinal cord and gut. The goal is to track how often severe side effects occur and improve safety for future patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Re-irradiation (radiation therapy)
- What this could lead to
- If successful, this could establish safer, more precise re-irradiation methods for patients with recurrent solid tumors, potentially reducing severe side effects.
- What could go wrong
- This is an observational analysis, not a treatment trial, so it won't directly prove a new therapy works. Results may not apply to all tumor types or radiation techniques.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed informed consent 2. Patients ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s). 3. Prior radiation dosimetry must be available. 4. Participants must have stage I-IV biopsy proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site). Documentation of pathology reports are required. Local review of pathology or cytology is at the discretion of the multidisciplinary team. 5. Histologic confirmation of target lesion recurrence is recommended. 6. Documentation of consensus for recommendation of reirradiation by multidisciplinary team and location of target lesion or postoperative site to be treated. 7. Documentation of whether or not concurrent cancer therapy drugs are recommended and rationale. 8. Documentation of rationale for not obtaining tissue confirmation of the target lesion, if applicable. 9. Baseline target lesion imaging with CT, positron emission tomography (PET) /CT, or MRI is required within six weeks of trial enrollment. CT or MRI simulation scans may be used for baseline imaging. 10. Patients who have had disease resected in a previously irradiated field and are at high pathological and clinical risk for recurrence as defined by the treating Radiation Oncologist and multidisciplinary team, are eligible for study. 11. Measurable disease is not required for patients being treated postoperatively. 12. Baseline labs are per standard practice. Values will be dependent on the OARs being treated. (Per standard practice, radiation therapy volumes to OARs are modified to accommodate compromised renal, liver, pulmonary or other OAR function). Recommended labs and values include: * Aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN) or \< 5 x ULN with metastatic liver disease. * Total bilirubin \< 1.5 x ULN * Absolute neutrophil count (ANC) \> 500 cells/mm\^3 * Platelets \> 50,000 cells/mm\^3 * Creatinine \< 1.5 x ULN or Creatinine clearance \> 45 mL/min if creatinine is \> 1.5 x ULN (calculated Creatinine Clearance (CrCl) based on Cockcroft-Gault equation) 13. Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2. 14. Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2. 15. Life expectancy of at least 6 months. 16. Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation. 17. Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English). 18. Concurrent participation on pharmaceutical, investigator-initiated, National Clinical Trials Network (NCTN), or other multisite clinical trials that include re-irradiation is allowed. Exclusion Criteria: 1. Patients receiving low dose radiation for symptom management only. 2. Patients with evidence of severe or uncontrolled systemic conditions. 3. Life expectancy of less than 6 months. 4. ECOG Performance status ≥ 3. 5. Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Froedtert Hospital
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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